bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
FDA Recall Z-0243-2007 · Posted 2006-12-05
Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMDB
Date Initiated2006-08-17
Date Terminated2009-12-08
Product Quantity34,440
Reason for Recall
Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
Firm Action
Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.
Root Cause
Other
Distribution Pattern
Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.